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Analysis of Influencing Factors of Preoperative Frailty in Elderly Patients With Gastric Cancer Based on the Health Ecology Theory

Analysis of Influencing Factors of Preoperative Frailty in Elderly Patients With Gastric Cancer Based on the Health Ecology Theory

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04929587
Enrollment
406
Registered
2021-06-18
Start date
2021-01-01
Completion date
2022-02-02
Last updated
2022-04-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Frailty, Gastric Cancer

Brief summary

Frailty is common in patients with gastric cancer undergoing surgical treatment. Preoperative frailty can lead to many adverse outcomes in patients after surgery. This study aims to comprehensively and systematically analyze the influencing factors of preoperative frailty in patients with gastric cancer based on the health ecology theory , to change some critical variable factors in the future, improving the overall prognosis of patients.

Interventions

OTHERThis is a observational research, there is no intervention

This is a observational research, there is no intervention

Sponsors

Nanjing Medical University
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
OTHER

Eligibility

Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Clinical diagnosis of gastric cancer * Age over 60 years old * With clear surgical indication

Exclusion criteria

* Malignant tumors in other parts of the body * Severe cardiopulmonary complications * Receive palliative surgery * Have received preoperative radiotherapy and chemotherapy

Design outcomes

Primary

MeasureTime frameDescription
Frailty assessed by Frailty Phenotype (FP)preoperative periodThe total score is 0\ 5, and a score of 0\ 3 is considered as frailty.

Secondary

MeasureTime frameDescription
Nutrition assessed by Nutrition Risk Screening 2002 (NRS2002)preoperative periodNRS2002 comprises 3 components: nutritional status, disease status and age, with a total score ranging from 0 to 7. A score of ≥3 is considered to be at nutritional risk.
Anxiety and depression assessed by Hospital Anxiety Depression Scale (HADS)preoperative periodHADS contains 2 subscales: anxiety and depression subscales. Each subscale consists of 7 items, with a total score ranging from 0 to 21. A score of each subacale reaches 8 or more is regarded as the presence of anxiety or depression.
Social support assessed by Social Support Rate Scale (SSRS)preoperative periodSSRS contains 10 items and 3 dimensions, which are objective support, subjective support, and support utilization, with higher scores indicating higher degrees of the corresponding dimensions.
Familial caring degree assessed by Family Concern Index Questionnaire (APGAR)preoperative periodThe total score ranges from 0 to 10, and a score of ≤6 is considered as having family dysfunction.
Sleep assessed by Pittsburgh Sleep Quality Index (PSQI)preoperative periodA total score range from 0 to 21, a score of 0\ 5 indicates very good sleep quality; a score of 6\ 10 indicates good sleep quality; a score of 11\ 15 indicates poor sleep quality; a score of 16\ 21 indicates very poor sleep quality.

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026